A Study of DTaP//PRP-T Combined Vaccine (ACTACEL) Versus Local DTaP and Act-HIB Monovalent Vaccine in Healthy Infants

• ClinicalTrials.gov Identifier: NCT01062477
• Recruitment Status: Completed
• First Posted: February 4, 2010
• Last Update Posted: December 13, 2011
• Sponsor: Sanofi
• Information provided by (Responsible Party): Sanofi

Study Description

Brief Summary:

The purpose of this study is to assess the immunogenicity and safety of ACTACEL combined vaccine in support of registration of this product in China

Primary Objectives:

• To demonstrate that ACTACEL vaccine administered at 2, 3 and 4 months of age or at 3, 4 and 5 months of age is not inferior, in terms of seroprotection, to Wuhan's Diphtheria, Tetanus, acellular Pertussis (DTaP) and Haemophilus influenzae type b (Act-HIB) vaccine given concomitantly, for diphtheria, tetanus, and Polyribosyl Ribitol Phosphate (PRP) antigens, one month after the three-dose primary vaccination.
• To demonstrate the superiority, in terms of seroconversion, of ACTACEL vaccine administered at 2, 3 and 4 months of age or at 3, 4 and 5 months of age for Pertussis Toxoid (PT), Fimbriae types 2 and 3 (FIM2) and (FIM3) pertussis antigens, compared with Wuhan's DTaP and Act-HIB vaccines given concomitantly, one month after the three-dose primary vaccination.

Secondary Objectives:

• To describe the safety after administration of the study vaccines.
• To describe in each group the immunogenicity of the study vaccines one month after the primary vaccination and before and one month after the booster vaccination.

Condition or disease	Intervention/treatment	Phase
Diphtheria; Tetanus; Pertussis; Haemophilus Influenzae Type B	Biological: DTaP//PRP-T Combined Vaccine; Biological: DTaP Combined Vaccine and PRP-Tetanus Conjugate Vaccine	Phase 3

Detailed Description:

Participants will receive a primary vaccination consisting of three doses of ACTACEL at either 2, 3, and 4 months of age or at 3, 4, and 5 months of age; or Wuhan DTaP and Act-HIB vaccines at 3, 4, and 5 months of age. All participants will receive a single booster dose at 18-20 months of age and will be followed up for one month after the last dose of study vaccine.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1056 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Safety and Immunogenicity of the Sanofi Pasteur's DTaP//PRP-T Combined Vaccine (ACTACEL) Versus Local DTaP and Hib Conjugate (Act-HIB) Monovalent Vaccine as a Three-dose Primary and Booster Vaccination in Healthy Infants in China
• Study Start Date: January 2010
• Actual Primary Completion Date: September 2011
• Actual Study Completion Date: December 2011

Arms and Interventions

Arm	Intervention/treatment
Experimental: Study Group 1; Participants will receive ACTACEL vaccine at 2, 3, and 4 months of age.	Biological: DTaP//PRP-T Combined Vaccine; 0.5 mL, Intramuscular; Other Name: ACTACEL
Experimental: Study Group 2; Participants will receive ACTACEL vaccine at 3, 4, and 5 months of age.	Biological: DTaP//PRP-T Combined Vaccine; 0.5 mL, Intramuscular; Other Name: ACTACEL
Active Comparator: Study Group 3; Participants will receive Wuhan DTaP and Act-HIB vaccines concomitantly at 3, 4 and 5 months of age.	Biological: DTaP Combined Vaccine and PRP-Tetanus Conjugate Vaccine; 0.5 mL, Intramuscular (each vaccine); Other Name: Act-HIB™

Outcome Measures

Primary Outcome Measures :

1. Immunogenicity: To provide information concerning the immunogenicity of ACTACEL vaccine after primary and booster vaccination. [ Time Frame: One month post-vaccination ]

Secondary Outcome Measures :

1. Safety: To provide information concerning the safety after primary and booster administration of ACTACEL vaccine. [ Time Frame: 0-7 days post-vaccination and entire study duration ]

Eligibility Criteria

• Ages Eligible for Study: 60 Days to 89 Days (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria :

• Aged 2 months on the day of inclusion
• Born at full term pregnancy (≥ 36 weeks) with a birth weight ≥ 2.5 kg
• Informed consent form signed by the parent(s) or legal representative
• Participant and parent/legal representative able to attend all scheduled visits and to comply with all trial procedures

Exclusion Criteria :

• Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination
• Planned participation in another clinical trial during the present trial period
• Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy since birth, or long-term systemic corticosteroids therapy
• Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances
• Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator
• Receipt of blood or blood-derived products since birth that might interfere with the assessment of immune response
• Receipt or planned receipt of any vaccine in the 4 weeks preceding or following any trial vaccination (except oral poliovirus (OPV), bacillus Calmette-Guérin (BCG), and Hepatitis B vaccines which cannot be given within 8 days before or after any study vaccination)
• History of seizures
• Known personal or maternal Human Immunodeficiency Virus (HIV), Hepatitis B (HB) surface antigen or Hepatitis C seropositivity
• History of diphtheria, tetanus, pertussis or Haemophilus influenzae type b infection (confirmed either clinically, serologically or microbiologically)
• Previous vaccination against diphtheria, tetanus, pertussis or Haemophilus influenzae type b disease with either the trial vaccine or another vaccine
• Participant at high risk for diphtheria, tetanus, pertussis or Haemophilus influenzae type b infection during the trial
• Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular vaccination
• History of contraindication to vaccination with pertussis-containing vaccine
• Febrile illness (axillary temperature ≥37.1°C) or moderate or severe acute illness/infection on the day of inclusion, according to Investigator judgment

Temporary contraindications that must be resolved before vaccination:

• Acute febrile illness within the 72 hours preceding the vaccination, or temperature ≥37.1°C present at this visit
• Any vaccination in the 4 weeks preceding the vaccination (except OPV, BCG, and hepatitis B vaccines which cannot be given within 8 days before or after any study vaccination)
• Systemic corticosteroids therapy (prednisone or equivalent) for more than 2 consecutive weeks within the past 3 months

Contacts and Locations

Locations

China, Guangxi

LingChuan County, Guilin City, Guangxi, China, 541200

Lipu County, Guilin City, Guangxi, China, 546600

Sponsors and Collaborators

Sanofi

Investigators

• Study Director: Medical Director; Sanofi Pasteur Inc.

More Information

Additional Information:

Related Info 

• Responsible Party: Sanofi
• ClinicalTrials.gov Identifier: NCT01062477
• Other Study ID Numbers: C5A06; UTN: U1111-1112-2509 ( Other Identifier: WHO )
• First Posted: February 4, 2010
• Last Update Posted: December 13, 2011
• Last Verified: December 2011

Keywords provided by Sanofi:

Diphtheria Tetanus Pertussis Haemophilus Influenzae Type B

Additional relevant MeSH terms:

Whooping Cough; Tetanus; Diphtheria; Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Bordetella Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Clostridium Infections; Gram-Positive Bacterial Infections; Corynebacterium Infections; Actinomycetales Infections; Vaccines; Immunologic Factors; Physiological Effects of Drugs